Urinary Steroid Metabolites in Autism
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Purpose
Deviation of hormone formation within nerve cells and nerve system provides autism spectrum disorder and neurodevelopment retardation through interacting of steroids with neurotransmitter-receptors, calcium-channel receptors and genomic interaction via nuclear steroid receptors.
Urinary steroid metabolites will be compared between children with autism spectrum disorder and healthy controls.
| Condition |
|---|
|
Autism Autism Spectrum Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder |
- difference in hormone formation and androgen precursors [ Time Frame: 3 years ] [ Designated as safety issue: No ]Calculation of hormone formation by comparison of urinary steroid metabolites
- difference in hormone formation in gender and age [ Time Frame: 3 years ] [ Designated as safety issue: No ]Hormone formation depends on age and gender and will be calculated by comparison of urinary steroid metabolites
Biospecimen Retention: Samples Without DNA
noninvasive overnight urine (morning urine)
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
autistic boys
Boys with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician
|
|
autistic girls
Girls with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician.
|
|
control boys
Healthy boys, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger-Syndrome" (MBAS).
|
|
control girls
Healthy girls, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger Syndrome" (MBAS).
|
Detailed Description:
Autism spectrum disorder presents many alterations in amino acid metabolism and in neurotransmitter systems (gamma amino acid system, glutamate-glutamine, nicotine-acid, serotonin-system) . Also alteration in gene activation within nerve cells and lymphocyte cultures encloses over 600 genes, affecting a wide field of enzymes , metabolic pathways and hormone formation. Male hormones and their precursors are often increased and their influence to nerve cell growth and spine formation is evident.
The diagnosis of autism spectrum disorder is made in accordance of criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) of the American Psychiatric Association by an experienced and specialised paediatrician or psychologist and /or by an Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule (ADOS) .
Overnight urine with measurement of quantity and time will be collected and a little part of the urinary samples will be frozen for storage till analysis. Age, weight and length of the children at collection time will be ascertained.
Four stratified groups (autistic boys, girls, and healthy controls, boys and girls, each age 5-15) will be formed.
Urinary samples will further remain anonymous through an Identification-Number (ID).
Analysis of hormones and the most of the known metabolites excreted in urine will be performed by a specialised laboratory using gas chromatography-mass spectrometry (GC/MS) analysis (University Hospital Bern, Steroid Laboratory, Switzerland).
The statistical analysis, with age, gender, weight, diagnosis and hormone analysis results as factors , consists in linear regression analysis to detect deviation in hormone formation and metabolism.
Eligibility| Ages Eligible for Study: | 5 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children , age 5-15 years with autism and autism spectrum disorder resident in Austria without other severe or psychiatric disorders.
Inclusion Criteria:
- Autism spectrum disorder
- Age 5-15 years
Exclusion Criteria:
- Epilepsia
- Psychotropic medication
- other severe illness
Contacts and Locations| Austria | |
| Intersci Research Association | |
| Leibnitz, Steiermark, Austria, 8430 | |
| Principal Investigator: | Johann Kurz, MD | Intersci Research Association, Austria |
More Information
Additional Information:
Publications:
| Responsible Party: | Kurz Johann MD, Medical Doctor,, Intersci Research Association, Austria |
| ClinicalTrials.gov Identifier: | NCT01197131 History of Changes |
| Other Study ID Numbers: | protocol 1.0/18/06/2010 |
| Study First Received: | September 8, 2010 |
| Last Updated: | March 31, 2013 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Intersci Research Association, Austria:
|
autism autism spectrum disorder steroids steroid metabolites |
urinary steroid metabolites hormone formation androgen precursor |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013